The U.S. Food and Drug Administration approved obinutuzumab in combination with chemotherapy, followed by obinutuzumab alone, for the firstline treatment of patients with stage II bulky, stage III, or stage IV follicular lymphoma (FL).

The approval was based on results from the international, phase III GALLIUM study, which randomized 1,401 treatment-naïve patients with indolent non-Hodgkin lymphoma (1,202 of whom had FL) to receive obinutuzumab in combination with chemotherapy, followed by obinutuzumab alone (n=601), or rituximab plus chemotherapy, followed by rituximab alone (n=601).